The Food and Drug Administration announced on Friday that it's postponing its meeting that's scheduled for Feb. 15 to discuss the emergency authorization use of the Pfizer-BioNTech COVID-19 vaccine in young children.
Pfizer notified the FDA about "additional findings from its ongoing clinical trial" for the use of the vaccine in children ages 6 months through 4-years-old.
The meeting was scheduled to go over a two-dose regimen, but the FDA requested time to go over the data with regards to a three-dose regimen for children in that age group.
"We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," the FDA said in the statement.
Pfizer said that data on the third dose will be available in April.
The FDA went on to say that the recent surge of COVID-19 cases due to the omicron variant also impacted their decision.
"Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study," the FDA said.
The FDA added that data on the third dose is important to consider before approving the emergency authorization request.
"Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered," the FDA said.
There are nearly 18 million children ages 6 months though 4-years-old in the United States that would be eligible for the vaccine. White House COVID-19 response coordinator, Jeff Zients, said on Wednesday that the government was prepared to roll out vaccines for younger children once the FDA approved authorization.
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